Globus Medical Announces Clinical Results Showing Superiority of its SECURE-C® to ACDF at Seven Years
“The long-term evidence shown in this study confirms the outstanding results I have seen in my own patients treated with SECURE-C®,” said Dr.
The prospective, randomized Investigational Device Exemption (IDE) trial involved a total of 380 study subjects (240 investigational and 140 control) to compare the safety and effectiveness of SECURE-C® to ACDF using a cervical plate and structural allograft for patients with intractable symptomatic cervical disc disease (SCDD) at a single level in the cervical spine. At seven years post-surgery, SECURE-C® patients reported greater overall satisfaction with surgery and exhibited the following:
- Statistically superior composite overall success results (86.3%) compared to ACDF patients (70.0%);
- Greater improvement in pain and function based on the Neck Disability Index (90.4%) versus ACDF patients (86.0%);
- Lower rate of subsequent surgery (4.2%) at the original treated level compared to ACDF patients (15.3%); and
- Lower rate of adjacent level surgery (4.2%) versus ACDF patients (16.0%).
“The seven-year clinical study findings provide further evidence for statistical superiority of SECURE-C® to ACDF in terms of overall success, bolstering the long term data on cervical arthroplasty,” said
The SECURE-C® Cervical Artificial Disc is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The SECURE-C® Cervical Artificial Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation of the SECURE-C® Cervical Artificial Disc.
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Source: Globus Medical